The Bipolar Lithium Imaging Scan Study.
ConditionBipolar Disorder I or II
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLeiden University Medical Center
About this trial
The main goal of this study is to determine if brain lithium-concentrations predict clinical lithium treatment-response. Secondary, to study correlations between intracerebral distribution-patterns of lithium with clinical treatment outcome.
Brain lithium concentrations will be measured using ultra-high field (7 Tesla) lithium magnetic resonance (MR) imaging, which has recently been introduced. Determining lithium-concentrations in the brain has been difficult so far due to lithium's relatively low concentration (compared to protons, which are targeted in conventional MRI). 7T lithium MR imaging has the potential to produce much more detailed MR images compared with previous studies, for the first time. The BLISS study is expected to yield new insights, helping to better understand why clinical lithium response varies between individuals.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age 18 years or above,
a clinical diagnosis of bipolar disorder type I or type II ,
having reached stable therapeutic serum lithium concentrations (reference values 0.6-1.0 mM in age to 65 years; 0.4-0.8 in age 65 years and above) within four weeks prior to study participation, and
provided written informed consent.
Disqualifiers
insufficient comprehension of the Dutch language,
unable to provide informed consent,
drug or alcohol abuse over a period of two weeks prior to study participation, and
meeting any exclusion criterium for MR imaging.
Trial population
Subjects with bipolar disorder type I or II who start with lithium treatment as part of standard care.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Lithium MR imaging
Other interventionAfter obtaining written informed consent and within four weeks of reaching a stable therapeutic serum lithium concentration, lithium MR imaging will be performed using a 7 Tesla MR system (Achieva, Philips Medical Systems, Eindhoven, The Netherlands) with a dual-tuned 7Li/1H volume head coil (RAPID Biomedical GmbH, Rimpar, Germany). Various approaches, including whole-brain, voxel-wise, parcellation, mean, and regions of interest, will be applied to measure lithium concentrations.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: BLISS candidates1 intervention
Trial outcomes
Primary outcomes
1
Clinical lithium response
Clinical lithium response will be assessed using a validated questionnaire.
Time frame
At 12-month follow-up.Secondary outcomes
1
Serum lithium concentrations
Serum lithium concentrations will be determined to establish correlations with brain lithium concentrations.
Time frame
BaselineOther outcomes
1
Manic and depressive symptom severity
Manic and depressive symptom rating scales will be used to assess mood state at the day of scan acquisition.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov